a prospective, single center clinical study of toripalimab combined with flot regimen for perioperative treatment of pd-l1 positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma (gej)

Conditions: PD-L1 Positive Locally Advanced Patients With Resectable Gastric Cancer

Summary: in this study, patients with pd-l1 positive locally advanced patients with resectable gastric cancer or gastroesophageal junction adenocarcinoma were invited to participate in the study.to evaluate the efficacy and safety of patients with pd-l1 positive gastric cancer or gastroesophageal junction adenocarcinoma (≥t3 and the number of lymph node metastasis ≥1, and no distant metastasis) using toripalimab combined with docetaxel, oxaliplatin, fluorouracil, leucovorin (flot regimen) .


Eligibility criteria:
inclusion criteria: 1. informed consent of the patient; 2. 18 years old \<age \<75 years old; 3. the researcher judged that he could comply with the study protocol; 4. histologically confirmed gastric or gastroesophageal junction adenocarcinoma (siewert ii-iii); 5. clinical stage at admission: ≥t3 with ≥1 lymph node metastasis and no distant metastasis (ajcc 8th) * esophagogastroduodenoscopy must be performed * diagnostic laparoscopy must be performed 6. immunohistochemistry confirmed that the patient was pd-l1 positive (cps≥1); 7. preoperative ecog \[using the ecog scoring standard zubrod-ecog-who (zps, 5-point method) developed by the eastern cooperative oncology group (ecog)\] physical state score 0/1; 8. preoperative asa score i-iii; 9. expected survival ≥12 weeks; 10. the baseline blood routine and biochemical parameters of selected patients should meet the following criteria: * hemoglobin ≥90g/ l, which can be met by blood transfusion; * absolute neutrophil count ≥1.5×10\^9/ l * platelet count ≥100×10\^9/ l * aspartic acid or alanine aminotransferase ≤ 2.5 times the upper limit * alkaline phosphatase ≤ 2.5 times normal upper limit (uln), * thyroid stimulating hormone (tsh) ≤1 times uln (if abnormal, t3 and t4 levels should be investigated at the same time; if t3 and t4 levels are normal, they can be included in the group); exclusion criteria: 1. inestigators identified stage iv (metastatic) or unresectable gastric or gastroesophageal junction adenocarcinoma 2. previous systemic treatment for gastric cancer 3. have a history of allergy to any component of terriprizumab, oxaliplatin, capecitabine; 4. received any of the following medical treatment: a. have received anti-pd-1 or anti-pd-l1 antibody therapy in the past; b. have received any investigational drug treatment within 4 weeks before using the drug for the first time; c. enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; d. receive the last dose of anti-cancer treatment (including radiotherapy) within 4 weeks before the first use of the study drug;; e. receive systematic treatment with corticosteroids (\> 10mg prednisone equivalent daily dose) or other immunosuppressants within 2 weeks prior to their first use of the study drug; f. those who have been vaccinated with anti-tumor vaccines or the study drugs have been vaccinated with live vaccines within 4 weeks before the first administration; g. those who have undergone major surgery or trauma within 4 weeks before using the study drug for the first time; 5. history of other malignant diseases within 5 years; 6. history of active autoimmune disease or autoimmune disease 7. the subject has cardiovascular clinical symptoms or disease that is not well controlled; 8. severe infection 4 weeks prior to first use of study drug (ctcae \> level 2) 9. a history of interstitial lung disease (except for radiation pneumonia not treated with chinese hormone) or non-infectious pneumonia; 10. patients with active pulmonary tuberculosis infection found by history or ct examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis interference history more than 1 year ago but without formal treatment; 11. pregnant or lactating women; 12. suffering from severe mental illness.